Given these existing differences in youth risk, applicants need to provide robust evidence to demonstrate that using their menthol-flavored e-cigarette products are likely to promote complete switching or are likely to significantly reduce cigarette use in adult smokers beyond that facilitated by tobacco-flavored e-cigarette products. ![]() Additionally, data indicate tobacco-flavored e-cigarettes do not have the same appeal to youth and therefore do not pose the same degree of risk of youth uptake. Recent data from the 2022 National Youth Tobacco Survey found most (84.9%) youth who used e-cigarettes in the past 30 days used non-tobacco-flavored e-cigarettes, and of them, 26.6% used menthol-flavored e-cigarettes. In reviewing PMTAs for tobacco products, the FDA evaluates the risks and benefits of those tobacco products to the population as a whole, including users and nonusers of the tobacco product, and takes into account, among other things, the likelihood that those who do not currently use tobacco products will start using those tobacco products.įor non-tobacco-flavored e-cigarettes, including menthol-flavored e-cigarettes, existing evidence demonstrates a known and substantial risk with regard to youth appeal, uptake and use. Under the PMTA pathway, applicants must demonstrate to the agency that permitting the marketing of a new tobacco product would be appropriate for the protection of the public health. The company may resubmit applications or submit new applications to address the deficiencies for the products that are subject to these MDOs.īefore permitting the marketing of a product under the PMTA pathway, among other things, the agency reviews a tobacco product’s components, ingredients, additives, constituents, design, harmful and potentially harmful constituents and health risks, as well as how the product is manufactured, packaged, and labeled. The evidence provided within the application does not demonstrate that these menthol-flavored e-cigarettes are more effective in promoting complete switching or significant cigarette use reduction relative to tobacco-flavored e-cigarettes among adult smokers. “We remain committed to evaluating new tobacco products based on a public health standard that considers the risks and benefits of the tobacco product to the population as a whole.”Īfter reviewing the company’s premarket tobacco product applications (PMTAs), the FDA determined that the applications lacked sufficient evidence to demonstrate that permitting the marketing of the products would be appropriate for the protection of the public health, the applicable standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act. “Ensuring new tobacco products undergo premarket evaluation is a critical part of the FDA’s work to reduce tobacco-related disease and death,” said Brian King, Ph.D., M.P.H., director of the FDA’s Center for Tobacco Products. ![]() These are the first menthol e-cigarette products to receive a marketing decision based on a full scientific review from the FDA. As a result, the company must not market or distribute these products in the United States or risk enforcement action by the FDA. The currently marketed products include the Logic Pro Menthol e-Liquid Package and Logic Power Menthol e-Liquid Package. Food and Drug Administration issued marketing denial orders (MDOs) for several e-cigarette products currently marketed by Logic Technology Development LLC (Logic). ![]() ![]() The stay does not constitute authorization to market, sell or ship Logic products. All electronic nicotine delivery systems, including those made by Logic, are required by law to have FDA authorization to be legally marketed. Court of Appeals for the Third Circuit entered a stay pending review of the marketing denial order for Logic Technology Development LLC.
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